1. Field of the Invention
The invention relates to an adaptor that can be mounted between an end of an indwelling urethral catheter and a connector to an urinary drainage bag to prevent or reduce the incidence of urinary tract infection in a patient who needs to wear an indwelling urethral catheter during the course of the medical treatment.
2. Description of the Prior Art
Indwelling urethral catheterization in a closet drainage system is the standard of care in present day modern medical care for a patient who has bladder neck obstruction such as benign prostatic hypertrophy, or urinary incontinence such as neurogenic bladder, in surgery requiring perioperative urine output monitoring or for the patient being observed and treated in an intensive care unit requiring close urine output monitoring. Nosocomial urinary tract infection invariably develops within one week after a FOLEY catheter, i.e. an urethral catheter with a retention balloon at one end, is left indwelling. Ascending infection by microorganisms through a lumen of the urethral catheter is thought to be one of the causes of nosocomial urinary tract infection. Conventional treatments include oral and intravenous antimicrobial therapy and intermittent irrigation of the urethral catheter with antibiotics and acetic acid solution. The treatments frequently fail to eradicate and control the urinary tract infection. Resistant strains of microorganisms frequently supersede, rendering the subsequent treatment more difficult and expensive and mortality hence increases.
The present invention provides apparatus and methods for connecting and reconnecting catheters, such as indwelling catheters, and in particular FOLEY urinary drainage catheters, from and to drainage bags and other external reservoirs, collection devices and the like. In particular, the present invention significantly reduces the risk of infection when an indwelling catheter is disconnected from and reconnected to a series of external collection devices of the type just mentioned. In the exemplary embodiments, the present invention provides for introducing an antiseptic material to the region where the catheter is being disconnected as an automatic part of the disconnection/reconnection procedure. That is, the system user need take no steps other than disconnecting and reconnecting the indwelling catheter to the external device, whereby the present invention automatically dispenses an antiseptic material to reduce the risk of infection. Although particularly suitable for use with FOLEY catheters, the present invention will also find use with other indwelling and transcutaneous catheters, such as implanted catheters used for exchanging dialysate with peritoneal catheters for ambulatory peritoneal dialysis.
Apparatus according to the present invention comprises an adaptor for connecting the end of the catheter, typically an indwelling FOLEY catheter as described above, to a connector on a collection bag, typically a urinary collection bag in the case of a FOLEY catheter. The adaptor comprises an adaptor body having a flow passage therethrough with a first connector at one end of the flow passage and a second connector at the other end of the flow passage. The first connector is adapted to removably connect a catheter, typically a proximal hub or other connector on a FOLEY catheter and to receive fluid from the connected catheter. The second connector is adapted removably connect and attach to the collection bag or other external device. A chamber which holds a liquid antiseptic is further provided, typically being part of the adaptor body, preferably being disposed annularly about the adaptor body. A valve is included in the flow passage and has a first position where the flow passage is open and a second position where the flow passage is closed. The valve has a valve passage which receives a dose of the antiseptic material from the chamber each time the valve is closed and releases the dose of antiseptic material into the flow passage each time the valve is opened. In this way, each time the user turns off the valve to disconnect the urinary collection bag or other device, a dose of the antiseptic will automatically be collected in the passage of the valve mechanism. Then, after the collection bag is reconnected, the valve is opened and the valve passage automatically releases the antiseptic into the flow path between the indwelling catheter and the collection bag. The release of antiseptic will greatly reduce the risk of infection becoming established and travelling up the indwelling catheter to harm the patient.
In the exemplary embodiments, the valve comprises a rotary plug having the flow passage therein. The plug may be rotated so that the valve passage is in alignment with the flow passage in the adaptor body in order to open the valve. Similarly, the valve may be rotated so that the valve passage is out-of-alignment with the flow passage in the adaptor body in order to close the valve. With such configuration, the antiseptic material may be conveniently dispensed by providing openings between the chamber holding the antiseptic and the rotary plug, where the openings are positioned in the adaptor body so that fluid flows into the valve passage each time the valve is closed and the valve passage falls out of alignment with the flow passage. In one exemplary embodiment, the plug rotates about an axis which is perpendicular to the valve passage. In another embodiment, the plug rotates about an axis parallel to but spaced laterally apart from the valve passage.
The present invention further comprises methods for inhibiting infection of an indwelling catheter, such as a FOLEY urinary drainage catheter. The catheters are connected to a receptacle, usually a drainage bag, and a valve is provided in a connecting line to isolate the proximal end of the indwelling catheter when it is desired to remove one drainage bag and replace it with an empty drainage bag or other receptacle. The method comprises closing the valve between the indwelling catheter and the drainage receptacle and introducing a dose of antiseptic material into a valve passage of the closed valve. The drainage bag may then be disconnected and a new bag reconnected while the valve remains closed. When the valve is opened to reestablish a drainage path from the catheter to the drainage bag, the antiseptic material is automatically released through the valve and into the connecting line between the catheter and the drainage bag. As described above with respect to the device, such release of antiseptic material greatly reduces the risk of infection travelling up the indwelling catheter to the patient.
The antiseptic introducing step usually comprises positioning the valve passage to receive a dose from a chamber located adjacent the valve, typically located annularly about the valve an flow passage in the adaptor. Usually, the valve will be positioned to receive antiseptic each time it is closed and further positioned to release antiseptic to the indwelling catheter and/or the drainage bag each time the valve is opened. The volume of antiseptic material released will typically be in the range from 0.1 ml to 10 ml, and suitable antiseptic materials include betadine, acetic acid solution, hydrogen peroxide, and the like. It will also be possible to use antibiotics in place of or in combination with antiseptic agents.